The first patient was dosed in a phase 2b clinical trial evaluating rhenium (186Re) obisbemed, a new injectable radiotherapy, for the treatment of recurrent glioblastoma, a type of brain cancer.
Researchers conducting the ReSPECT-GBM trial will evaluate the safety, tolerability, distribution and efficacy of rhenium (186Re) obisbemed, according to a press release from Plus Therapeutics, the drug’s maker. The treatment will be injected directly into the tumor via a catheter after conventional treatment.
The trial is expected to enroll up to 31 additional patients with small to medium-sized tumors (20 milliliters or less) over approximately 24 months, according to the release.
It was previously reported that the results of a phase 1 study evaluating rhenium (186Re) obisbemed in 24 patients with recurrent glioblastoma showed a statistically significant improvement in overall survival (time from diagnosis or initiation of treatment when patients are alive). In addition, the treatment was safe and well tolerated.
“In the phase 1/2a dose-escalation trial, we demonstrated that the radiation dose of rhenium (186Re) obisbemed… can be safely administered and that there is a statistically significant correlation between overall survival and the absorbed radiation dose per tumor and the percentage of tumor volume in the treated volume, ” said Dr. Andrew J. Brenner, lead study author and professor of medicine in neurology and neurosurgery at the University of Texas Health Science Center at San Antonio, in a statement. “The strength of this correlation is unusually positive for a phase 1/2a trial and we are optimistic that these safety and efficacy signals will be confirmed in the ongoing phase 2b trial.”
Moreover, the Food and Drug Administration has granted orphan drug designation for this patient population. Specifically, this designation is given when a pharmaceutical company developing a drug qualifies for certain incentives, including tax credits for a qualified clinical trial. This also gives the company an expedited designation, which is given to a drug that has the potential to treat a serious condition or fill an unmet need with the purpose of speeding up the development and review process, the Agency said.
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